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FDA 510(k)

LATEX CONDOMS NATURAL COLOUR WITH SILICONE OIL LUBRICANT

K-Number: K974323 · 1998-02-10

ApplicantReddy Medtech Health Products , Ltd.
Decision Date1998-02-10
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

LATEX CONDOMS NATURAL COLOUR WITH SILICONE OIL LUBRICANT is the device name listed in this FDA 510(k) record. The listed applicant is Reddy Medtech Health Products , Ltd.. It received FDA 510(k) clearance on 1998-02-10 under 510(k) number K974323. The device is classified under product code HIS. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LATEX CONDOMS NATURAL COLOUR WITH SILICONE OIL LUBRICANT?

LATEX CONDOMS NATURAL COLOUR WITH SILICONE OIL LUBRICANT is a medical device that received FDA 510(k) clearance on 1998-02-10. The listed applicant is Reddy Medtech Health Products , Ltd.. The 510(k) number is K974323.

When did LATEX CONDOMS NATURAL COLOUR WITH SILICONE OIL LUBRICANT receive FDA 510(k) clearance?

LATEX CONDOMS NATURAL COLOUR WITH SILICONE OIL LUBRICANT received FDA 510(k) clearance on 1998-02-10, under 510(k) number K974323.

Who is the listed applicant for LATEX CONDOMS NATURAL COLOUR WITH SILICONE OIL LUBRICANT?

The FDA 510(k) record lists Reddy Medtech Health Products , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LATEX CONDOMS NATURAL COLOUR WITH SILICONE OIL LUBRICANT?

The FDA product code for LATEX CONDOMS NATURAL COLOUR WITH SILICONE OIL LUBRICANT is HIS.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Reddy Medtech Health Products , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K980019HTL MALE CONDOMK974326LATEX CONDOMS (NATURAL COLOUR)K974324LATEX CONDOMS COLOUR WITH SPERMICIDAL LUBRICANT

Related Devices (Code: HIS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262108FAMA Male Latex Condoms – Aqueous Lubricant (Ultra-thin);FAMA Male Latex Condoms – Aqueous Lubricant (Plain);FAMA Male Latex Condoms – Aqueous Lubricant (Ribbed);FAMA Male Latex Condoms – Aqueous Lubricant (Dotted);FAMA Male Latex Condoms – Aqueous Lubricant (Non-regular Shaped);MO Male Latex Condoms – Aqueous Lubricant (Ultra-thin);MO Male Latex Condoms – Aqueous Lubricant (Plain);MO Male Latex Condoms – Aqueous Lubricant (Ribbed);MO Male Latex Condoms – Aqueous Lubricant (Dotted);MOShanghai Personage Hygiene Products Co., Ltd.K252622Male Latex Condom HAOkamoto USA, Inc.K252521LifeStyles® HydraFeel Natural Rubber Latex CondomSuretex LimitedK250034Natural rubber latex male condomShaoguan Regenex Pharmaceuticals Co., Ltd.K243421Lelo Hex Lubricated Natural Rubber Latex CondomLelo, Inc.K243640Trojan™ Ultra Ribbed Ecstasy latex condom with lubricant (Trojan™ Ultra Ribbed Ecstasy)Church & Dwight Co., Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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